MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MINI HUMERAL TRAY STANDARD THICKNESS +3 MM TAPER OFFSET 40 MM DIAMETER; PROSTHESIS, EXTREMITIES

Catalog Number	110031402
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-04119, 0001822565-2020-04121.Device product code - phx.Concomitant medical devices: part# 110030777; lot# 64515980; part# 110031421; lot# 64354411; part# 010000589; lot# 662130.Foreign - event occurred in (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
Patient underwent shoulder arthroplasty approximately five (5) weeks ago.Post-implantation, patient was getting out of the bathtub when the incident occurred on an unknown date.X-rays were taken approximately one (1) week post-implantation, where a disassociation was noted.Patient was revised two (2) days after x-rays were taken.It was originally assumed that the glenosphere dislodged from baseplate.During the retrieval of the glenosphere, it was additionally noticed that the poly had also dislodged from the tray, causing the glenosphere to migrate.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of radiographs.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.Radiographs identified the following: reverse left total shoulder arthroplasty with implant assembly and dislocation of the glenosphere which is now within the soft tissues of the lateral shoulder.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).Updated: b4, b5, d9, g3, h1, h2, h3, h6, h10.Reported event is still considered confirmed as visual examination of the returned product identified the glenosphere is severely scratched and gouged on the articulating surface.The mini humeral tray standard thickness +3 mm taper offset 40 mm diameter has cosmetic minor scuffs.The bearing standard 40 mm diameter is severely scratched, gouged and worn on the majority of all surfaces.A definitive root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: MINI HUMERAL TRAY STANDARD THICKNESS +3 MM TAPER OFFSET 40 MM DIAMETER
• Common Device Name: PROSTHESIS, EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 11020442
• Report Number: 0001822565-2020-04120
• Device Sequence Number: 4396546
• Product Code: PHX
• UDI-Device Identifier: 00887868231346
• UDI-Public: (01)00887868231346
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K181611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 110031402
• Device Lot Number: 64634029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2020
• Supplement Date Received by Manufacturer: 05/26/2021; 12/01/2021
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 05/28/2021; 12/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/02/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male